Quality Control Analyst I

Role: Quality Control Analyst I- Kronos 

(Quality Control Lab - Environmental Monitoring)

Duration: 6 Months

Location: Hayward, CA

NO VISAS, NO SPONSORSHIPS

Summary

• Conduct environmental monitoring of ISO 5, 7, 8, and 9 cleanrooms at Company manufacturing facilities along with Product Process monitoring, Gas testing and Water collection. Work under supervision. 
• Support Conduct specific chemical and physical analysis on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods.

Essential Duties and Responsibilities

• Collect environmental monitoring samples throughout the facility following 
• Standard Operating Procedures on a defined frequency.
• Operate equipment such as SAS Air Sampler and Non- Viable Particle
• Counter for the purpose of collecting air/particulate samples.
• Perform surface sample testing using plate and/or swab method.
• Collect water samples throughout the facility on a weekly/monthly basis.
• Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms.
• QC Data entry in Sample manager- LIMS.
• Complete all testing, including special project / protocol testing in a timely and appropriate manner.
• Perform equipment maintenance and calibrations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Support laboratory investigation and conduct nonconformance investigation
• Ensure Environmental Monitoring area is always maintained in a GMP state while following all EHS and 6S guidelines.
• Flexibility to perform other duties, as assigned, or as business needs require.
• Works and communicates effectively and professionally with others inside and outside the company.
• Weekend work may be required as needed to meet production timeline schedules.

Qualifications

• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Demonstrates some knowledge of assays/equipment in functional area. 
• Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
• Proficient use of laboratory equipment and tools. Must be detail-oriented, conscientious, and responsible. Must have effective verbal and written communication skills. Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs.
• Must be able to learn new computer systems and programs in a timely manner.

Education and/or Experience

• B.S. degree in Microbiology, Biology, or related science
• 0-2 years of experience; minimum 1 year experience in 
• Pharmaceutical/Medical Device industry preferred.

Physical Demands

• Regular attendance is necessary to perform the essential functions of the job.
• Light work, frequent lifting up to 10 lbs; frequent standing/walking.

Working Environment

• May be required to work or be assigned to a different shift to meet business needs.
• Must be willing to work off shift hours. Must be able to work supplemental hours as necessary to complete work commitments. May be required to work in a confined area.
• Primarily inside working conditions. Some clean room and cool/hot storage